What is FDA Part 11?
Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):
Records that are required to be maintained under predicate rule requirements and that are maintained in electronic format in place of paper format. On the other hand, records (and any associated signatures) that are not required to be retained under predicate rules, but that are nonetheless maintained in electronic format, are not part 11 records.
We recommend that you determine, based on the predicate rules, whether specific records are part 11 records. We recommend that you document such decisions.
Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.
In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.
Accordingly, we recommend that, for each record required to be maintained under predicate rules, you determine in advance whether you plan to rely on the electronic record or paper record to perform regulated activities. We recommend that you document this decision (e.g., in a Standard Operating Procedure (SOP), or specification document).
Records submitted to FDA, under predicate rules (even if such records are not specifically identified in Agency regulations) in electronic format (assuming the records have been identified in docket number 92S-0251 as the types of submissions the Agency accepts in electronic format). However, a record that is not itself submitted, but is used in generating a submission, is not a part 11 record unless it is otherwise required to be maintained under a predicate rule and it is maintained in electronic format.
Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule (e.g. approved, reviewed, and verified).
Source: Part 11, Electronic Records; Electronic Signatures - Scope and Application. U.S Food & Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application
DocuSign is an electronic signature solution and not intended as a long-term storage solution for University records. A copy of completed documents will reside in DocuSign no longer than 18 months.
It is the sender's responsibility to ensure the official/public record is archived in a long-term storage solution, retained and destroyed in accordance with the VCU Records Management policy and time periods listed in the Library of Virginia’s Retention and Disposition Schedules.
For a list of applications approved for long-term storage, please visit Technology Services Where Can I Store My Data? page.
Requesting Elevated Access
Only trained personnel within certain departments may be given access to send documents for signature in the Part 11 system. Complete the required Part 11 training in REDCap at: https://redcap.vcu.edu/surveys/?s=8KNWMERRPK
Once Part 11 training has been completed, users in the following units may contact their designated office to request access to begin using DocuSign Part 11:
- School of Medicine Research Administration Office
- Brian Washington, email@example.com
- Jason Elswick, firstname.lastname@example.org
- Letitia Rivers, email@example.com
- Massey Cancer Center Clinical Trials Office
NOTE: VCU employees with a @vcuhealth.org email address must use their eID@vcu.edu for actions requiring elevated access. Issues logging on to VCU CAS should be reported to the VCU Technology Services IT Support Center at 828-2227.
Electronic signatures are legally binding in the United States and most countries around the world. The ESIGN Act of 2000 defined the legality and enforceability of electronic signatures across all 50 states. The ESIGN Act ensures that contracts and signatures cannot be denied validity or enforceability because they are in electronic form. In Virginia state law, the Uniform Electronic Transactions Act supports the use of electronic records and electronic signatures for transactions between parties each of which has agreed to conduct transactions by electronic means. VCU's agreement is shown to each new recipient in DocuSign. The recipient must read and agree to the VCU terms before viewing or taking action on the documents sent them.
Permissible Uses of DocuSign Part 11
DocuSign Part 11 may only be used when obtaining remote consent signatures for an FDA-regulated study or if a sponsor requires it to sign documents for a specific study. Other research documents may be signed in the regular DocuSign website.
Potential FDA forms needing to be signed in DocuSign Part 11 include
- Form FDA 1571
- Form FDA 1572
- Form FDA 3454
- Form FDA 3455
- Form FDA 3674
- Form FDA 3926
- Protocol signature pages
Prohibited Uses of DocuSign Part 11
DocuSign Part 11 may not be used during in-person research consenting. It may also not be used to document the assent of children.
If you are using an iPad, iPhone, Android or Windows device, you can easily sign documents from your mobile web browser. Mobile application signing is not allowed.
Enables departments to download envelopes, documents, and data from DocuSign for use with other University systems. See the DocuSign Developer Center for more information: https://developers.docusign.com/
Prepare documents for rapid sending with reusable templates that save tags and field placement, workflow routing, and other settings. Templates standardize processes, reduce preparation time and enable end-to-end automation.